Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-028"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2008-10-22"^^xsd:date2
dcterms:Is Part Of	lp_eu:Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)2
dcterms:Language	"de"^^xsd:language2
lpv:document identification number	"en.20081022.2.3-028"2
lpv:hasSubsequent	lp_eu:2008-10-22-Speech-3-0292
lpv:speaker	lp:Thomas Ulmer2
lpv:spokenAs	unknown; Christlich Demokratische Union Deutschlands (2004-07-20--2009-07-13)3 substitute; Delegation to the ACP-EU Joint Parliamentary Assembly (2004-09-15--2009-07-13)3 substitute; Delegation for relations with Switzerland, Iceland and Norway and to the European Economic Area (EEA) Joint Parliamentary Committee (2004-09-15--2009-07-13)3 substitute; EMPL (2007-01-31--2009-07-13)3 member; EPP-ED (2004-07-20--2009-07-13)3 member; Delegation for relations with the Korean Peninsula (2007-03-14--2009-07-13)3 substitute; Temporary Committee on Climate Change (2007-05-10--2009-02-04)3 member; ENVI (2007-01-31--2009-07-13)3
lpv:translated text	"Mr President, Commissioner, ladies and gentlemen, I should like to congratulate Mrs Grossetête on her draft report on variations to the terms of marketing authorisations for medicinal products. I must make two brief comments on what previous speakers have said. As I see it, new medicinal products represent an opportunity to treat and cure health conditions, and the risk is proportionate. In addition, in the Federal Republic of Germany, for example, active ingredients already exist in many pharmaceutical forms and under many names without any increase in risk. The main focus of this Regulation, however, is the simplification of variations; that is, of the partial extension or variation of the pharmaceutical form of a medicinal product. Current practice is extremely cumbersome and entails a great deal of bureaucracy for companies, and the competent authorities are occupied with relatively inefficient measures. Therefore, the amendment creates a rare win-win situation. The report significantly improves safety and reliability in the internal market. In addition, thanks to the work in committee, numerous other interests have been taken into account that further expedite or simplify the procedure. For example, sufficient account has been taken of the issue of national authorisations, thus avoiding a duplication of effort. Due account has also been taken of the interests of Germany and German pharmaceutical companies. The draft has been aligned with omnibus proposal EU/2008/0032. The extension of marketing authorisations under other names has been expressly simplified. It has been made easier to supplement or extend product characteristics. I am as satisfied and positive today about the report by Mrs Grossetête as I was critical about the Jørgensen report yesterday evening. The Grossetête report goes in the right direction: towards the Lisbon process objective of becoming the most efficient knowledge-based area in the world. I support this report."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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